Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma

Amgen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma; Sarcoma; Soft Tissue Sarcoma

Treatments: Drug: Doxorubicin; Drug: AMG 655; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626704

20060324

Details and patient eligibility

About

This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed soft tissue sarcoma
• Locally advanced, recurrent, or metastatic, unresectable disease
• Measurable disease according to modified RECIST
• ECOG performance status of 0 or 1
• Men or women at least 18 years of age
• Adequate hematological, renal, hepatic, and coagulation function

Exclusion criteria

• Prior treatment with anthracyclines
• Uncontrolled cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

AMG 655 + Doxorubicin

Treatment:

Drug: AMG 655

Drug: Doxorubicin

Arm 2

Placebo Comparator group

Description:

Placebo + Doxorubicin

Treatment:

Other: Placebo

Drug: Doxorubicin